Blog
RSS FeedPosted by Michael Wonder on 23 Jun 2020
FDA maintains the pace of meeting its goals on applications for medical products during the pandemic
23 June 2020 - One of the challenges facing the FDA during the COVID-19 pandemic is how to ensure the ...
Posted by Michael Wonder on 23 Jun 2020
FDA announces first of its kind pilot program to communicate patient reported outcomes from cancer clinical trials
23 June 2020 - The U.S. FDA today launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence. ...
Posted by Michael Wonder on 23 Jun 2020
Imbruvica (ibrutinib) seeks to expand U.S. label with long-term data in Waldenström's macroglobulinaemia
23 June 2020 - Submission is based on results of more than five years of follow-up data from the Phase 3 ...
Posted by Michael Wonder on 23 Jun 2020
Myovant Sciences announces priority review and FDA acceptance of new drug application for once daily, oral relugolix for advanced prostate cancer
22 June 2020 - Priority review status expected to accelerate review, with a target FDA action date of 20 December ...
Posted by Michael Wonder on 22 Jun 2020
FDA approves selinexor for relapsed/refractory diffuse large B-cell lymphoma
22 June 2020 - Today the Food and Drug Administration granted accelerated approval to selinexor (Xpovio, Karyopharm Therapeutics) for adult ...
Posted by Michael Wonder on 22 Jun 2020
European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines
22 June 2020 - Senior officials from the European Commission, EMA and the United States FDA held their 2020 bilateral ...
Posted by Michael Wonder on 22 Jun 2020
FDA accepts supplemental biologics license application for Botox (onabotulinumtoxinA) for the treatment of paediatric patients with neurogenic detrusor overactivity
22 June 2020 - Application seeks to extend use of Botox for patients 5 to 17 years old. ...
Posted by Michael Wonder on 21 Jun 2020
FDA approves new Dupixent (dupilumab) pre-filled pen designed to support more convenient self-administration
19 June 2020 - 300 mg pre-filled pen expected to be available third quarter of 2020. ...
Posted by Michael Wonder on 21 Jun 2020
Coronavirus attacks the lungs. A federal agency just halted funding for new lung treatments.
19 June 2020 - The shift, quietly disclosed on a government website, highlights how the Trump administration is favouring development of ...
Posted by Michael Wonder on 20 Jun 2020
Nabriva Therapeutics receives complete response letter from FDA on NDA for Contepo (fosfomycin) for injection
19 June 2020 - Agency cited travel restrictions and inability to conduct onsite inspections to resolve observations at manufacturing partner facilities. ...
Posted by Michael Wonder on 20 Jun 2020
FDA approves Evoke’s Gimoti
19 June 2020 - Commercial partner Eversana prepares for Gimoti launch. ...
Posted by Michael Wonder on 20 Jun 2020
Plakous Therapeutics receives rare paediatric disease and orphan drug designations for Protego-PDTM for the prevention of necrotising enterocolitis
18 June 2020 - Plakous Therapeutics has been granted orphan drug and rare paediatric disease designations for its human placental extract, ...
Posted by Michael Wonder on 20 Jun 2020
Ovid Therapeutics receives FDA rare paediatric disease designation for OV101 for the treatment of Angelman syndrome
19 June 2020 - Ovid Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease ...
Posted by Michael Wonder on 19 Jun 2020
Dicerna receives rare paediatric disease designation from U.S. FDA for nedosiran for the treatment of primary hyperoxaluria
18 June 2020 - Dicerna Pharmaceuticals today announced that the U.S. FDA has granted rare paediatric disease designation for nedosiran, ...
Posted by Michael Wonder on 18 Jun 2020
FDA takes additional action to harness real world data to inform COVID-19 response efforts
18 June 2020 - Today the U.S. Food and Drug Administration has taken an additional step in harnessing real-world data to ...